Clinical Research Associate Specialist
hace 1 mes
The Initiation Clinical Research Associate II plays a key role in the start-up process of clinical trials. As a direct point of contact with assigned sites, this role is accountable for quality and delivery during the start-up phase. Key responsibilities include building relationships with investigators and site staff, generating visit/contact reports, developing strategies to configure and distribute high-quality documents, and preparing and submitting IRB/IEC and MoH/RA applications.
Key Accountabilities:- Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
- Develop strategy to configure, distribute, collect, review and approve high-quality country-specific and/or site-specific documents.
- Prepare and submit IRB/IEC and MoH/RA application(s), resolving conflicts, determining appropriate follow-up until receipt of final approval.
- Strong problem-solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Client-focused approach to work.
- Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of the issues that arise.
- Fluent command of Spanish and English languages.
Previous experience in study set up/site initiation/study start-up experience or equivalent experience in clinical research environment, with understanding of clinical trials methodology and terminology, including experience with EU CTR.
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